Comparison of the Effects of Mirror Therapy,rTMS and Robotic-assisted Hand Therapy in Stroke Patients

Afyonkarahisar Health Sciences University

Status: Enrolling

Conditions: Stroke; Quality of Life; Upper Extremity Dysfunction; Neuropathic Pain; Neurologic Disorder

Treatments: Device: Device: Low Frequency rTMS Protocol; Other: Procedure: Mirror therapy; Device: Robotic-assisted hand therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06750692

SBH2025

Details and patient eligibility

About

The aim of the study is to investigate the comparison of the effects of mirror therapy, Repetitive Transcranial Magnetic Stimulation and robot-assisted hand therapy added to conventional neurological rehabilitation on upper extremity function, quality of life and pain in stroke.

Full description

Stroke is the second leading cause of death in adults and an important cause of long term disability. Functional limitations that develop in the post stroke period affect participants quality of life and activities of daily living. Today, despite advances in rehabilitation and new pharmacologic strategies, stroke related upper extremity function, quality of life and pain treatment may not always achieve the desired results. There are new approaches in stroke rehabilitation such as mirror therapy, Repetitive Transcranial Magnetic Stimulation, robot-assisted hand therapy. Three groups will take part in this study. All three groups will receive a total of 20 sessions of conventional neurological rehabilitation program 5 days a week for 4 weeks. In addition to the first group, a total of 20 sessions of upper extremity mirror therapy program will be applied for 4 weeks, 5 sessions per week. The second group will receive Repetitive Transcranial Magnetic Stimulation (rTMS) to the contralateral M1 upper extremity motor cortex region at low frequency (1Hz) and at an intensity of 100%-110 of the resting motor threshold, 5 sessions per week for a total of 20 sessions for 4 weeks. The third group will receive a total of 20 sessions of robot-assisted hand therapy using AMADEO (Tyromotion Austria) 5 days a week for 4 weeks.These three groups will be compared in terms of upper extremity function, quality of life and pain.Brunstroom, Mini Mental Test, Modified Ashworth Scale, Fugl Meyer Upper Extremity Motor Assessment Scale, Box Block Test, Nine Hole Pag Test, ABILHAND Stroke Hand Function Questionnaire, Stroke Impact Questionnaire, Stroke Specific Quality of Life Scale, Visual Analog Scale , LANNS neuropathic pain assessment scale, 4 Question Neuropathic Pain Questionnaire, Beck Depression Inventory, Beck Anxiety Scale, Pittsburgh Sleep Quality Index, MEP (motor evoked potential) measurement will be done . Participants will be evaluated by a physician twice at the beginning and at the end of treatment (4th week).

Enrollment: 120 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who applied to Afyonkarahisar Health Sciences University Hospital Physical Medicine and Rehabilitation Polyclinic with the diagnosis of hemiplegia after a cerebrovascular accident in the inpatient ward or as an outpatient for neurological rehabilitation after taking the anamnesis and physical examination, who met the inclusion criteria and eliminated the exclusion criteria
• Female and male patients between the ages of 40-80
• stroke at least 3 months ago
• voluntarily agreed to participate in the study regularly, whose health status is suitable for rehabilitation and who are medically stable
• mini mental test score of 15 and above
• Neurologically stable patient

Exclusion criteria

• significant comorbidities such as serious heart disease (aortic stenosis, angina, hypertrophic cardiomyopathy, arrhythmia, pacemaker) and uncontrolled hypertension
• history of epilepsy, antiepileptic drug use
• intracranial metal objects
• intraauricular implants
• cognitive dysfunction
• upper extremity peripheral nerve injuries
• malignancy
• active infection
• skin infections or open wounds in the application area
• inflammatory diseases
• orthopedic injuries that may limit maximum effort capacity
• brain lesion or drug use history that may affect the seizure threshold
• increased intracranial pressure
• uncontrolled migraine
• severe spasticity in the hand (MAS≥3)
• contracture in the hand
• have had a fracture or surgery on the hemiplegic side in the last 6 months
• severe visual impairment
• severe depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Experimental: Mirror therapy

Experimental group

Description:

The first group of participants will receive mirror therapy for 4 weeks, 5 sessions per week for a total of 20 sessions of upper extremity mirror therapy.

Treatment:

Other: Procedure: Mirror therapy

Experimental: Low Frequency rTMS Protocol

Experimental group

Description:

The second group will receive a total of 20 sessions of Repetitive Transcranial Magnetic Stimulation (rTMS) to the contralateral M1 upper extremity motor cortex region at low frequency (1Hz) and intensity of 100%-110% of the resting motor threshold, 5 sessions per week for 4 weeks.

Treatment:

Device: Device: Low Frequency rTMS Protocol

Experimental: Robotic-assisted hand therapy

Experimental group

Description:

In the Robot Assisted Therapy group, a total of 20 sessions will be applied to the hemiplegic upper extremity with AMADEO (Tyromotion Austria) 5 days a week for 4 weeks.

Treatment:

Device: Robotic-assisted hand therapy